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| Name | Class |
|---|---|
| Instacart Health | UNKNOWN |
| Kentucky Association of Health Plans | UNKNOWN |
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This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery prescription with delivery through Instacart at the start of the study or after 12 weeks or frozen medically tailored meals delivered from Door Dash. Researchers will compare the grocery prescription program, MTM (medically tailored meals), relative to standard of care to see if the impact on these food as medicine programs can improve glucose control over 12-weeks as compared to standard of care.
Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who report food insecurity using the Hunger Vital Signs Screener will be recruited to participate in a comparative study across two urban communities. One arm will receive a grocery prescription program from Instacart Health to be spent on eligible healthy food items based on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered to their door each week. The meals are based on diabetes guidelines and are culturally appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville, Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be recruited initially from a registered nurse who works at the clinic sites. The study team will then enroll participants after eligibility screening and conduct further onboarding into the food as medicine package based on locations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grocery Prescription Program | Experimental | Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately |
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| Standard Medical Care | Active Comparator | the delayed control group will receive their usual care through their healthcare provider and then participate in Fresh Funds or MTM after the initial 12-weeks of intervention. |
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| MTM (medically tailored frozen meals) | Experimental | Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh Funds for Mom's | Behavioral | Participants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks. Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in fasting blood glucose | Fasting blood glucose obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart. | baseline and post intervention, approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in food insecurity | The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity. | baseline and post intervention, approximately 12 weeks |
| Change in self efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Gustafson, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States | ||
| U of L Health |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005502 | Food |
| D004304 | Dosage Forms |
| C099588 | myotubularin |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004364 | Pharmaceutical Preparations |
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| Standard Medical care | Behavioral | Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks or be provided the medically tailored meals for 12 weeks. |
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| Medically Tailored Frozen Meals | Behavioral | Participants will enroll in the MTM program. Once enrolled participants will receive 10 frozen meals delivered by Door Dash to their home each week for 12 weeks. |
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The self efficacy scale for diabetes measures the confidence in managing diabetes. Scores range from 1 to 10 with a higher score indicating greater confidence in managing diabetes.
| baseline and post intervention, approximately 12 weeks |
| Change in blood pressure | Diastolic and systolic Blood pressure will be obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart. | baseline and post intervention, approximately 12 weeks |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| D004700 | Endocrine System Diseases |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |